On August 29, 2021 InnoCare Pharma (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported 2021 half year results which ended on June 30, 2021 (Press release, InnoCare Pharma, AUG 29, 2021, View Source [SID1234586982]).
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Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "On the foundation of solid development in the past five years, we continue to make breakthroughs in various projects in the first half of 2021. Our business development (BD) team made significant progress, reaching out-licensing and in-licensing cooperation with Biogen and Incyte respectively. Our commercial team delivered a satisfactory result as we entered into the lymphoma market for the first time. Our R&D and clinical development projects have been progressing well. To conclude, we are continuously achieving our milestones."
Financial Highlights
Sales revenue increased from 0.7 million for the six months ended on June 30, 2020 to 101.7 million for the six months ended on June 30, 2021, due to sales from orelabrutinib.
Other income and gains increased by 69% year-on-year (YOY), from 50.6 million for the six months ended on June 30, 2020 to 85.3 million for the six months ended on June 30, 2021.
Our cash and bank balances increased by 58%, from 3.9696 billion by the end of 2020 to 6.2548 billion by the end of June 30, 2021.
The loss for the period decreased by 37%, from 337.4 million for the six months ended on June 30, 2020 to 213.1 million for the six months ended on June 30, 2021.
(Note: Currency: RMB)
Latest Corporate Development
On July 13, InnoCare entered into a license and collaboration agreement for orelabrutinib for the potential treatment of multiple sclerosis (MS) with Biogen.
Under the terms of the agreement, InnoCare will receive a US$125 million upfront payment and is eligible to receive up to US$812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of greater China (mainland China, Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in greater China.
The partnership with Biogen will further unleash commercial value of orelabrutinib.
On August 17, a subsidiary of InnoCare entered into a collaboration and license agreement for the development and commercialization of tafasitamab with Incyte, a humanized Fc-modified cytolytic CD-19 targeting monoclonal antibody, in Greater China. Under the terms of the agreement, InnoCare will receive the rights to develop and exclusively commercialize tafasitamab in hematology and oncology in greater China. InnoCare will pay Incyte US$35 million up front, and Incyte is eligible to receive up to an additional US$82.5 million in potential development, regulatory and commercial milestones, as well as tiered royalties.
Tafasitamab got market approval in the U.S. and Europe. The in-licensing will further strengthen InnoCare’s drug portfolio.
Product Highlights and Milestones
Orelabrutinib
Orelabrutinib has been included in the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines for Malignant Lymphoma 2021 and is listed as Class I recommended regimen for the treatment of r/r CLL/SLL and r/r MCL.
Over 400 patients have been treated with orelabrutinib across our B-cell malignant cancer trials. The clinical data indicate that orelabrutinib’s high target selectivity and exceptional target occupancy rate have resulted in favorable safety and efficacy profiles. There are multiple registrational and exploratory trials ongoing.
The registrational trail for r/r waldenstrom’s macroglobulinemia (WM) has completed patient enrollment. It is expected to submit the new drug application (NDA) in the first half of 2022.
The registrational trial for r/r marginal zone lymphoma (r/r MZL) is expected to complete patient enrollment in 2021 and submit NDA in 2022.
Phase III trial for first-line treatment of CLL/SLL is expected to complete in 2023.
Phase III trial of orelabrutinib in combination with R-CHOP as a first-line treatment for MCL is ongoing.
Phase I/IIa trial of orelabrutinib in combination with next generation CD20 antibody MIL-62 for the treatment of B-cell Non-Hodgkin lymphoma (NHL) in a basket trial is ongoing. InnoCare will announce its latest clinical data in the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) on Sept. 16 of 2021.
In the U.S., Phase II trial for r/r MCL is expected to complete in 2022. In June 2021, U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to orelabrutinib for the treatment of r/r MCL.
In addition to oncology, we are exploring orelabrutinib as a treatment therapy for various auto-immune diseases.
In the U.S., the first patient was dosed in Phase II trial for MS. This trial is being conducted globally, with active patient enrollment in Europe and China.
In China, Phase II trial for systemic lupus erythematosus (SLE) is expected to complete enrollment of 60 patients by October of this year and plan to announce the results in the first quarter of 2022.
Phase II clinical trial of orelabrutinib for the treatment of immune thrombocytopenia purpura (ITP) was approved by the NMPA and phase II study is being actively initiated
ICP-192 (gunagratinib)
InnoCare presented the latest clinical data at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. As of February 2021, a total of 30 patients had received the treatment of gunagratinib. Gunagratinib performed well in safety and tolerance, the maximum tolerated dose (MTD) had not been reached. Among the 12 patients with FGF/FGFR gene aberrations who have completed at least one tumor assessment, the overall response rate (ORR) was 33.3%, including 1 patient (8.3%) of cholangiocarcinoma with complete response (CR) and 3 patients (25%) with partial response (PR), 7 patients achieved SD. The disease control rate (DCR) was 91.7%.
Continue to advance phase II trial of advanced cholangiocarcinoma. Dose escalation in advanced solid tumors, aiming at expanding more indications with higher dose.
Gunagratinib was granted Orphan Drug Designation (ODD) for the treatment of cholangiocarcinoma by the U.S. FDA. Phase I trial is expected to complete in the first half of 2022.
ICP-723
In the Phase I dose escalation study (1mg, 2mg, 3mg and 4mg), ICP-723 showed efficacy in two patients with qualified neurotrophic tyrosine receptor kinase (NTRK) fusion. The NTRK fusion positive patient in 3 mg cohort reached stable disease (>20% tumor reduction) and the patient in 4 mg cohort achieved partial response (PR) at the first tumor assessment at the end of cycle 1, or day 28.
In the U.S., IND application was accepted for the treatment of NTRK fusion positive cancers.
ICP-332
In May 2021, the NMPA approved Phase I clinical trial of novel tyrosine kinase 2 ("TYK2") inhibitor, ICP-322. The first subject dosing was completed in August 2021. ICP-332 will be used to treat autoimmune diseases such as psoriasis, atopic dermatitis, etc.
ICP-033
The IND application for ICP-033 was approved by the NMPA in June 2021. ICP-033 is a novel Receptor Tyrosine Kinase (RTK) inhibitor and is intended to be used alone and in combination with immunotherapies and other targeted drugs for liver cancer, renal cell carcinoma, colorectal cancer and other solid tumors.
In addition to the above innovative drugs, we also have 5-7 IND-enabling stage drug candidates as below:
In the field of autoimmune diseases, ICP-488 is a small molecule binder of the pseudokinase domain (Janus Homology 2 or JH2) of TYK2, which is developed for the treatment of inflammatory diseases such as psoriasis and IBD. ICP-490 is a proprietary, orally available small molecule that modulates the immune system and other biological targets through multiple mechanisms of action. By specifically binding to CRL4CRBN-E3 ligase complex, ICP-490 can induce ubiquitination and degradation of transcription factors including Ikaros and Aiolos.
In the field of solid tumors, ICP-189 is a potent oral allosteric inhibitor of SHP2 with excellent selectivity over other phosphatases. ICP-B03 is a tumor-conditional pro-interleukin-15 (IL-15) targeting and changing immune cells inside tumor microenvironment. ICP-915 is a highly potent, selective small-molecule inhibitor against the G12C mutant form of Kirsten Rat Sarcoma (KRAS) viral oncogene homologue. ICP-915 may be developed as a monotherapy and cornerstone molecule for combinatory treatment of KRAS mutant solid tumors by tackling multiple modules of the RTK-RAS-MAPK signaling pathway.
In the field of liquid tumors, ICP-248 is a novel, orally bioavailable B-cell lymphoma-2 (BCL-2) selective inhibitor that is developed to be used as monotherapy and combinational treatment for hematological malignancies. ICP-B02 is a CD20xCD3 bispecific antibody co-developed with Keymed Biosciences for the treatment of lymphoma.
Other Corporate Development
In February, InnoCare brought on Hillhouse as strategic investor and Vivo Capital increased holdings, with total injected US$393 million.
In March, the Company proposed to issue RMB shares on the Science and Technology Innovation Board of the Shanghai Stock Exchange (Proposed Issue of RMB Shares).
In April, InnoCare successfully held the first R&D Day, with in-depth communication with investors and analysts online and offline.
In June, InnoCare launched its Shanghai Office in the New Bund Center.
"Looking forward to the second half of 2021, we will rapidly advance the product pipeline based on our core value of ‘Science drives innovation for the benefit of patients’. Our commercial team will continue to make efforts so that orelabrutinib can benefit more patients. For R&D projects, we will uphold the craftsman spirit of excellence, actively push forward our projects, pursue excellence, and achieve goals with high quality, so that we can achieve more milestones," added Dr. Cui.
To know more about the detailed financial data of InnoCare 2021 half year financial report, please log in View Source .
Conference Call Information
InnoCare will host a conference call on August 30, 2021 at 9:00 a.m. Beijing time. Participants must register in advance of the conference call. Details are as follows:
Registration Link: View Source
Conference ID: 3476988
The call will be conducted in Chinese.
Upon registering, each participant will receive a dial-in number, Direct Event passcode, and a unique access PIN, which can be used to join the conference call.